National Medicine Policy

PHARMACEUTICALS

PRESENTATION OUTLINE

What is it?

History of National Drug Policy

Background

Lesotho’s NMP aim

What are its objectives?

Components of NMP

Overview of components

Actors involved

Characteristics of a NMP

Assessment questions

What is it?

It is a political commitment and a guide for action that shows how the GOV will ensure that efficacious and safe medicines of good quality are affordable, accessible and rationally used.

It is a well established endorsed framework based on partnerships (WHO).

Governments, commonwealth, states, territories (SADC) and actors work together to promote the objectives of the NMP

HISTORY OF NDPs

1985 Nairobi Conference of Experts on rational Use of Drugs

1987 Working group of Experts to draft guidelines for NDP’s

1988 Guidelines for NDP’s released

1995 Expert Committee on NDPs met report issued

2002 New Guidelines were published

BACKGROUND

Medicines play a critical role in protecting, maintaining and restoring people’s health

Access of medicines is a concern for all national governments

Poor availability is a major problem for LDCs

Changing patterns of morbidity and Trade Agreements impact on access to medicines.

Political values, economic and legislation situations impact on access as well.

Background conti……

These access problems have persisted despite the efforts by GOVs, development agencies and WHO to improve on access to essential medicines.

The reasons for failure to achieve universal coverage and rational use are complex and differ among Countries and involve a wide range of stakeholders

Lesotho’s NMP

Aim: To improve and sustain, within the available resources , the health of the population of Lesotho by treating, curing, reducing or preventing disease conditions through the use of safe, effective, good quality, affordable medicines in both public and private sector.

What are its objectives

To ensure availability of medicines that meet the 4 criterions; quality, safety efficacy and affordability

To control, supervise and evaluate the quality of medicines

To promote rational use of medicines

To promote local production of medicines

To be a basis for development of medicines legislation and its enforcement

To guide HR development, ensure their retention and proper deployment

Components of NMP Legislation, regulation and guidelines(drugs of abuse Act 2008 and

donation guidelines)

Selection of medicines (STGs, EML & national formulary)

Supply and distribution (NDSO)

Quality Assurance (QC Lab is lacking, GPP exist)

Rational Use of medicines (3-5 items per prescription & 1-2 antibiotics out of 54% of prescription)

Financing and Pricing (no policy on pricing, GOV spend over M50 million)

Local production (LPC 51% GOV)

Monitoring & Evaluation of NDP’s

Medicines information and Pharmacovigilance

Human Resources Development (NUL & NHTC challenge of absorption)

International and regional Cooperation (Exists)

Traditional and complimentary medicines

Research and development

OVERVIEW OF COMPONENTS

Each component has a crucial part in the overall policy!

Emphasizing one component at the expense of others, weakens the entire policy

Many different actors are involved. Some are outside MoH, some outside GOV, some outside country

ACTORS INVOLVED

Doctors, specialists, public/private

Pharmacists retail and manufacturing

Local and international producers, importers

Consumers/Patients

Media

Regulators

Insurance Companies

ETC

CHARACTERISTICS OF NMPMust fit within the framework of the MOH care system.

Goals should be consistent with broader health objectives

Health policy and the level of service are important determinants of medicines policy and define the range of choices and options.

Implementation of an effective medicines policy promotes confidence in and use of health services

Planners need to be aware and not experts in all areas

Assessment questions?

Does Lesotho have a NMP?

Does it contain the objectives and strategies based on priority problems?

Do laws exist that specify the GOV’s responsibility in ensuring equitable access to essential medicines?

Does an implementation plan exist to put the policy into practice?

Is the policy monitored regularly?

Are legal mechanisms available to file complaints about lack of access?

So what?

IS ACCESS TO MEDICINES A ROLE OF INTERLLECTUAL PROPERTY LAW AND POLICY ONLY?THANK

YOU